An interventional study of Erector spinae plane block and Intrathecal morphine in Cesarean Section and Post Operative Pain, sponsored by AUSL Romagna Rimini. Recruiting at 1 site in Italy. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-10-01.
Sponsored by AUSL Romagna Rimini · Not applicable, Interventional, and Treatment
Cesarean section is a surgical procedure that involves significant pain, which is managed through a multimodal pharmacological approach.The primary objective of the study is to evaluate the quality of hospitalization after cesarean section using the QRo11 questionnaire in patients treated with a postoperative Erector Spinae Plane Block compared to those treated with intrathecal morphine.
Cesarean section is one of the most common surgical procedures worldwide and is associated with significant postoperative pain. Effective pain control is crucial to enhance maternal recovery, improve mobilization, support breastfeeding, and reduce hospital stay. Traditionally, intrathecal morphine has been widely used as part of a multimodal analgesic regimen. However, its use may be limited by opioid-related side effects such as nausea, vomiting, pruritus, and respiratory depression.
Regional anesthesia techniques targeting the thoracic paravertebral space have recently been introduced to improve postoperative pain control while reducing opioid consumption. The Erector Spinae Plane (ESP) Block is a relatively simple and safe fascial plane block that has shown promising results in different surgical settings, including obstetric procedures.
The primary aim of this prospective study is to evaluate the quality of recovery after cesarean section using the validated Quality of Recovery-11 (QoR-11) questionnaire. Patients will be allocated to receive either a postoperative ESP block or intrathecal morphine as part of their analgesic protocol.
Secondary endpoints include postoperative pain scores, opioid consumption, incidence of opioid-related side effects, time to mobilization, breastfeeding outcomes, and duration of hospital stay.
This study will provide new evidence on the role of the ESP block in cesarean section and may contribute to optimizing multimodal analgesia strategies for mothers undergoing this procedure.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's planned enrollment of 52 is below the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →AUSL Romagna Rimini is the lead sponsor of 13 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Patients in this group will receive an ultrasound-guided bilateral Erector Spinae Plane Block at the end of cesarean section, in addition to standard spinal anesthesia without intrathecal morphine.
Procedure: Erector spinae plane block
Patients in this group will receive a standard dose of intrathecal morphine during spinal anesthesia for cesarean section. No additional fascial plane block will be performed.
Procedure: Intrathecal morphine
Ultrasound-guided Erector Spinae Plane Block performed at the T9 level with 0,375%, ropivacaine 20 mL administered bilaterally at the end of surgery for postoperative analgesia following cesarean section.
Also known as: ESPB
Intrathecal administration of 100 mcg of morphine in combination with a local anesthetic was performed at the time of spinal anesthesia for cesarean section.
Also known as: ITM
QoR-11 questionnaire score
Assessment of QoR-11 questionnaire score
Time frame: day 1 after surgery
Numerical Rating Scale (NRS) pain scores
Assessment of Numerical Rating Scale (NRS) pain scores both at rest and during movement. NRS 0-10. 0 mean a better outcome, 10 mean a worse outcome.
Time frame: 4, 6, 8, 12, and 24 hours after cesarean section
rescue dose
Time to first rescue dose (interval between the block or intrathecal morphine administration and the first request for opioid analgesia).
Time frame: day 1 after surgery
complications
Assessment of adverse events such as sedation, nausea, and other complications
Time frame: day 1 after surgery
breastfeeding latch
Time from birth to first breastfeeding latch
Time frame: day 1 after surgery
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AUSL Romagna Rimini